A Safety and Tolerability Study of Assisted and Self-Admi... | NCT01566721

ID	Type	Description	Link
2011-005328-17	EudraCT Number

Label	Type	Description	Intervention Names
Cohort A: SC Herceptin by Needle/Syringe	Experimental	Participants will receive SC Herceptin by an assisted administration using a conventional syringe and needle/vial formulation.	Drug: Herceptin
Cohort B: SC Herceptin by SID	Experimental	Participants will receive SC Herceptin with assisted and/or self-administered use of an SID. The first administration will be performed by a trained healthcare professional. If well tolerated and the participant is willing and judged competent to perform self-administration, subsequent administration of SC Herceptin may be performed by the participant.	Drug: Herceptin

Name	Type	Description	Arm Group Labels	Other Names
Herceptin	Drug	Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.	Cohort A: SC Herceptin by Needle/Syringe Cohort B: SC Herceptin by SID

Measure	Description	Time Frame
Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period	Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with at least 1 AE during the treatment period (regardless of severity or seriousness) was reported.	From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period	Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.	From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)
Percentage of Participants With Treatment Interruption Due to an AE	Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. The percentage of participants with SC Herceptin treatment interrupted to assess or treat AEs was reported.

Measure	Description	Time Frame
Percentage of Participants Who Died by Data Cutoff of 10 March 2015	The percentage of participants who died from any cause was reported.	From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)
Percentage of Participants Who Died During the Safety Follow-up Period

Name	Affiliation	Role
Clinical Trials	Hoffmann-La Roche	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
University "Mother Theresa" Hospital Center; Oncology Department		Tirana		1000	Albania
CPMC; Service d'Oncologie Médicale

PubMed Identifier	Type	Citation	Retractions
30018134	Derived	Jung KH, Ataseven B, Verrill M, Pivot X, De Laurentiis M, Al-Sakaff N, Lauer S, Shing M, Gligorov J, Azim HA. Adjuvant Subcutaneous Trastuzumab for HER2-Positive Early Breast Cancer: Subgroup Analyses of Safety and Active Medical Conditions by Body Weight in the SafeHer Phase III Study. Oncologist. 2018 Oct;23(10):1137-1143. doi: 10.1634/theoncologist.2018-0065. Epub 2018 Jul 17.
28625777

ID	Title	Description
FG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
FG001	Cohort B: SC Herceptin by Single-Use Injection Device (SID)

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 11, 2016	Feb 10, 2021

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percentage of Participants With At Least 1 Adverse Event (AE) During the Treatment Period

Safety Population: All enrolled participants who received at least one dose of study medication according to assigned treatment.

Posted

Number

percentage of participants

From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)

ID	Title	Description
OG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Units	Counts
Participants	OG0001864 OG001709

Title

Denominators

Categories

Title	Measurements
	OG00088.6 OG00189.0

Primary

Percentage of Participants With a Grade 3 or Higher AE During the Treatment Period

Participants were planned to receive a total of 18 cycles of SC Herceptin. An AE was defined as any untoward medical occurrence in a participant administered SC Herceptin. Examples included unfavorable/unintended signs and symptoms, new or exacerbated disease, recurrence of intermittent condition, deterioration in laboratory value or other clinical test, or adverse procedure-related events. AEs were graded according to National Cancer Institute Common Terminology Criteria Version 4.0. Grade 3 AEs were those considered severe or medically significant but not immediately life-threatening. Grade 4 AEs were those considered life-threatening and/or for which urgent intervention was indicated. Grade 5 AEs were those resulting in death. The percentage of participants with a Grade 3 or higher (i.e., Grade 3 to 5) AE during the treatment period was reported.

Safety Population

Posted

Number

95% Confidence Interval

percentage of participants

From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)

ID	Title	Description
OG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Primary

Percentage of Participants With Treatment Interruption Due to an AE

Safety Population

Posted

Number

percentage of participants

From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)

ID	Title	Description
OG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Primary

Number of Herceptin Cycles Received

Participants were planned to receive a total of 18 cycles of SC Herceptin. The median number of cycles actually received was reported.

Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.

Posted

Median

Full Range

cycles

From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)

ID	Title	Description
OG000	Cohort B: SC Herceptin by SID (Self-Administered)	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self-administration.
OG001	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG002	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Primary

Percentage of Participants by Total Number of Herceptin Cycles Received

Participants were planned to receive a total of 18 cycles of SC Herceptin. The percentage of participants was reported by the total number of cycles actually received. Because the data are presented non-cumulatively, this table reflects participant distribution by the highest number of cycles received.

Safety Population. The endpoint also included an analysis of a subgroup of participants from Cohort B who received doses of self-administered SC Herceptin via SID.

Posted

Number

percentage of participants

From Day 1 up to 19 cycles (cycle length 3 weeks) (approximately 1 year)

ID	Title	Description
OG000	Cohort B: SC Herceptin by SID (Self- Administered)	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.
OG001	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG002

Primary

Percentage of Participants Who Received Concomitant Cancer Therapy

Concomitant cancer treatment included chemotherapy, radiotherapy, and hormone therapy administered during the study. The percentage of participants who received any of these concomitant therapies was reported.

Safety Population

Posted

Number

percentage of participants

From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)

ID	Title	Description
OG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Units	Counts
Participants

Primary

Percentage of Participants Who Received Concomitant Non-Cancer Therapy

Concomitant non-cancer treatment included any pharmacologic interventions administered during the study other than chemotherapy, radiotherapy, or hormone therapy. The percentage of participants who received any concomitant non-cancer therapies was reported.

Safety Population

Posted

Number

percentage of participants

From Baseline to data cutoff of 10 March 2015 (up to approximately 3 years)

ID	Title	Description
OG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Units	Counts
Participants

Secondary

Percentage of Participants Who Died by Data Cutoff of 10 March 2015

The percentage of participants who died from any cause was reported.

ITT Population

Posted

Number

percentage of participants

From Baseline to time of event (maximum follow-up approximately 3 years as of data cutoff of 10 March 2015)

ID	Title	Description
OG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Units	Counts
Participants

Secondary

Percentage of Participants Who Died During the Safety Follow-up Period

The percentage of participants who died from any cause was reported during the safety follow-up period.

ITT Population

Posted

Number

Percentage of Participants

From Baseline to Time of Event, Safety Follow-Up Period (Up to 6 Years)

ID	Title	Description
OG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Units	Counts
Participants

Secondary

Disease-Free Survival Rate

DFS is defined as the time from first dose of SC Herceptin to the first event of local, regional or distant recurrence, contralateral invasive breast cancer (including ipsilateral ductal carcinoma in situ) or death due to any cause.

Time from the date of first dose to any DFS event was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.

ITT Population who completed Safety Follow-up

Posted

Number

95% Confidence Interval

Kaplan-Meier survival probability

From Baseline to time of event (up to approximately 8 years)

ID	Title	Description
OG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Secondary

Overall Survival Rate

Overall survival was defined as the time from randomization to death from any cause.

Time from the date of randomization to the date of death was expressed in Kaplan-Meier survival probability estimates. Patients without an event will be censored at the last assessment date.

ITT population: All randomized participants received at least one dose of drug and completed the follow up period

Posted

Number

95% Confidence Interval

Kaplan-Meier survival probability

From Baseline to Time of Event (Up to Approximately 6 Years)

ID	Title	Description
OG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
OG001	Cohort B: SC Herceptin by SIDE	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.

Units

Secondary

Percentage of Participants by Item Response to SID Satisfaction Questionnaire

The SID satisfaction questionnaire was administered twice during the study and asked participants to respond to five statements using a Likert scale from "Strongly Disagree" to "Strongly Agree". Questionnaire items were as follows: "I felt comfortable injecting the study drug by myself" (Comfortable), "The SID was convenient and easy to use" (Easy to Use), "I am confident giving myself an injection in the thigh with the SID" (Confident), "Taking all things into account I find self-administration using the SID satisfactory" (Satisfactory), "If given the opportunity I would choose to continue self-injecting the study drug using the SID in the future" (Continue). Participants could only select one response per questionnaire item. There was no calculation of any score, but rather, descriptive summaries were generated by item response. The percentage of participants was reported by the response given for each item on the SID satisfaction questionnaire.

Safety Population. Only participants who performed self-administration were included. The number of participants who responded to the questionnaire item at each assessment (n) is shown in the table.

Posted

Number

percentage of participants

Cycle 4 (cycle length 3 weeks) and last safety follow-up (LSFU) (approximately 1 year)

ID	Title	Description
OG000	Cohort B: SC Herceptin by SID (Self- Administered)	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. Dosing was either performed by self-administration or a qualified HCP. The present subgroup included only participants for whom SC Herceptin was given by self- administration.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenic sepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0009 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG0030 affected707 at risk
Device related infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0006 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Pneumonia	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0005 events5 affected1,864 at risk EG0011 affected709 at risk EG0028 events8 affected1,862 at risk EG003
Urinary tract infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0003 affected1,864 at risk EG0012 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Mastitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0003 affected1,864 at risk EG0012 affected709 at risk EG0024 events4 affected1,862 at risk EG003
Cellulitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0004 affected1,864 at risk EG0010 affected709 at risk EG0024 events4 affected1,862 at risk EG003
Gastroenteritis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0003 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Lower respiratory tract infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0004 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Appendicitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0011 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Upper respiratory tract infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Breast abscess	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Erysipelas	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Infectious colitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Pyelonephritis acute	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Viral infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Infective exacerbation of chronic obstructive airways disease	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Abscess of external auditory meatus	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Appendiceal abscess	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Bartholin's abscess	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Breast cellulitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Bronchitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Bronchopneumonia	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Clostridium difficile infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Dengue fever	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Diverticulitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Febrile infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Gastroenteritis rotavirus	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Hepatitis B	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Herpes zoster	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Intestinal sepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Lobar pneumonia	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Localised infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Lung infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Lymph node tuberculosis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Meningoencephalitis bacterial	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Periorbital cellulitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Pneumonia bacterial	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Postoperative wound infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Pyelonephritis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Respiratory tract infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Skin infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Soft tissue infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Staphylococcal infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Tracheobronchitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Urosepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Vaginal infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Wound infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Febrile neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG00039 affected1,864 at risk EG00114 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Neutropenia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0009 affected1,864 at risk EG0016 affected709 at risk EG0020 affected1,862 at risk EG003
Febrile bone marrow aplasia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0012 affected709 at risk EG0020 affected1,862 at risk EG003
Anaemia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0003 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Leukocytosis	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Leukopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Pancytopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Thymus enlargement	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0008 affected1,864 at risk EG0014 affected709 at risk EG0020 affected1,862 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0005 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Pancreatitis	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0003 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Abdominal discomfort	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Colitis	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Constipation	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Gastritis erosive	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Gastrointestinal pain	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Intestinal polyp	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Neutropenic colitis	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Subileus	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Pyrexia	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG00011 affected1,864 at risk EG0017 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Device breakage	Product Issues	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0021 events1 affected1,862 at risk EG003
General physical health deterioration	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Asthenia	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Chest discomfort	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Chest pain	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Death	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0026 events6 affected1,862 at risk EG003
Device defective	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Fatigue	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Influenza like illness	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Mucosal inflammation	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Non- cardiac chest pain	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Oedema peripheral	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Cardiac failure congestive	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG00010 affected1,864 at risk EG0011 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Atrial fibrillation	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0026 events6 affected1,862 at risk EG003
Angina unstable	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Coronary artery disease	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Left ventricular dysfunction	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Myocardial ischaemia	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Pericarditis	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Supraventricular tachycardia	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Acute myocardial infarction	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0023 events3 affected1,862 at risk EG003
Atrial thrombosis	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Atrioventricular block second degree	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Myocarditis	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Palpitations	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Stress cardiomyopathy	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Ventricular arrhythmia	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Radiation pneumonitis	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Wound dehiscence	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Concussion	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Fibula fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Fracture displacement	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Laceration	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0022 affected1,862 at risk EG003
Seroma	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Spinal fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Tibia fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Traumatic arthropathy	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Ulna fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Wound	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0012 affected709 at risk EG0020 affected1,862 at risk EG003
Benign pancreatic neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Borderline serous tumour of ovary	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG00215 events15 affected1,862 at risk EG003
Clear cell renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0022 affected1,862 at risk EG003
Endometrial cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Ovarian fibroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Rectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Schwannoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Thyroid adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Headache	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Syncope	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0023 events2 affected1,862 at risk EG003
Aphasia	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Carotid sinus syndrome	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Cerebral ischaemia	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Cerebrovascular accident	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Depressed level of consciousness	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Epilepsy	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Generalised tonic-clonic seizure	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Peripheral sensorimotor neuropathy	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Presyncope	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Tension headache	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Transient ischaemic attack	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0022 events1 affected1,862 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0012 affected709 at risk EG0024 events4 affected1,862 at risk EG003
Dyspnoea exertional	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Organising pneumonia	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Painful respiration	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Pleurisy	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Hypertension	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Hypertensive crisis	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Aortic aneurysm	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Arterial stenosis	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Deep vein thrombosis	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Orthostatic hypotension	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Phlebitis	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Venous thrombosis	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Venous thrombosis limb	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Ejection fraction decreased	Investigations	MedDRA (18.0)	Non-systematic Assessment	EG0003 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
White blood cell count decreased	Investigations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Blood urea increased	Investigations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Electrocardiogram QT prolonged	Investigations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Neutrophil count decreased	Investigations	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Uterine polyp	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 events2 affected1,864 at risk EG0010 events0 affected709 at risk EG0023 events3 affected1,862 at risk EG003
Breast fibrosis	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 events1 affected1,864 at risk EG0010 events0 affected709 at risk EG0020 events0 affected1,862 at risk EG003
Endometrial hypertrophy	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Postmenopausal haemorrhage	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Uterine haemorrhage	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Gout	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Hypokalaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Dermatitis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Dermatitis bullous	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Erythema nodosum	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Toxic skin eruption	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Transient acantholytic dermatosis	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Anxiety	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Depression	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0011 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Panic attack	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Psychotic disorder	Psychiatric disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Renal failure	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Hydronephrosis	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Urinary incontinence	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Urinary retention	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Cholelithiasis	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0011 affected709 at risk EG0023 events3 affected1,862 at risk EG003
Cholecystitis chronic	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 affected1,862 at risk EG003
Drug hypersensitivity	Immune system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Hypersensitivity	Immune system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0012 affected709 at risk EG0020 affected1,862 at risk EG003
Vertigo	Ear and labyrinth disorders	MedDRA (18.0)	Non-systematic Assessment	EG0002 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Meniere's disease	Ear and labyrinth disorders	MedDRA (18.0)	Non-systematic Assessment	EG0001 affected1,864 at risk EG0010 affected709 at risk EG0020 events0 affected1,862 at risk EG003
Hypothyroidism	Endocrine disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0011 affected709 at risk EG0020 events0 affected1,862 at risk EG003
Thyroiditis Subacute	Endocrine disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Anaphylactic Shock	Immune system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Bile Duct Obstruction	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Bile Duct Stenosis	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Cholangitis Acute	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Hepatic Failure	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Hepatic Steatosis	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Acute Hepatic Failure	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0020 events0 affected1,862 at risk EG003
Cholecystitis	Hepatobiliary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Acute Kidney Injury	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Renal Colic	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Haematuria	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Nephrolithiasis	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Nephrotic Syndrome	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Urinary Bladder Polyp	Renal and urinary disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Lichen Sclerosus	Skin and subcutaneous tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Decreased Appetite	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Diabetes Mellitus	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 events0 affected1,864 at risk EG0010 events0 affected709 at risk EG0020 events0 affected1,862 at risk EG003
Endometrial Hyperplasia	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Breast Necrosis	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Cervical Dysplasia	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Fibrocystic Breast Disease	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Vaginal Haemorrhage	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Breast Calcifications	Reproductive system and breast disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Exostosis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Mobility Decreased	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Musculoskeletal Disorder	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Scleroderma	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Spinal Stenosis	Musculoskeletal and connective tissue disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Thromboangiitis Obliterans	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Varicose Vein	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 affected1,862 at risk EG003
Hypertensive Urgency	Vascular disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Pleural Effusion	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Pulmonary Sarcoidosis	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Cerebral Infarction	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Dementia	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Dementia Alzheimer's Type	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Relapsing-Remitting Multiple Sclerosis	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Seizure	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Amyotrophic Lateral Sclerosis	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Cerebral Haemorrhage	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Cerebrovascular Disorder	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Haemorrhagic Stroke	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Dizziness	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Hydrocephalus	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Sciatica	Nervous system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Papillary Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Uterine Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Ovarian Cancer Recurrent	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Ovarian Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Metastatic Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Lung Neoplasm Malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Gastrointestinal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Gastric Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Adenocarcinoma of Colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Lymphocytic Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Invasive Lobular Breast Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Invasive Ductal Breast Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Hepatocellular Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Glioma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Endometrial Adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Colon Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Chondroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Breast Sarcoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Breast Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Bladder Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Basal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Synovial Sarcoma Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events1 affected1,862 at risk EG003
Malignant Melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0023 events3 affected1,862 at risk EG003
Fall	Injury, poisoning and procedural complications	MedDRA (18.0	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Foot Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Foreign Body Aspiration	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Lower Limb Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Pubis Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Ankle Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0023 events3 affected1,862 at risk EG003
Femoral Neck Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0023 events3 affected1,862 at risk EG003
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Humerus Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Intentional Overdose	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events1 affected1,862 at risk EG003
Craniocerebral Injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Head Injury	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Incisional Hernia	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Joint Dislocation	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Post Procedural Haematoma	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Thoracic Vertebral Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Wrist Fracture	Injury, poisoning and procedural complications	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Myocardial Infarction	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0026 events6 affected1,862 at risk EG003
Acute Coronary Syndrome	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Angina Pectoris	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Arteriosclerosis Coronary Artery	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Atrial Flutter	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Atrial Tachycardia	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Cardiac Hypertrophy	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Cardio-Respiratory Arrest	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Tachycardia	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Intracardiac Thrombus	Cardiac disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Sudden Death	General disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Anal Fissure	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Diverticulum Intestinal	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Food Poisoning	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Gastritis	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Hiatus Hernia	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Intestinal Obstruction	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Small Intestinal Obstruction	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Upper Gastrointestinal Haemorrhage	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Inguinal Hernia	Gastrointestinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Escherichia Sepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0022 events2 affected1,862 at risk EG003
Biliary Tract Infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Chronic Sinusitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Dengue Haemorrhagic Fever	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Diabetic Gangrene	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Endocarditis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Enterobacter Sepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Gastroenteritis Viral	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Kidney Infection	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Post Procedural Cellulitis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Pulmonary Sepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Sepsis	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Pneumonia Influenzal	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Pneumonia Streptococcal	Infections and infestations	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Vulval Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Thyroid Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Renal Cell Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Pancreatic Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Ovarian Epithelial Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Non-Hodgkin's Lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Keratitis	Eye disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Anembryonic Gestation	Pregnancy, puerperium and perinatal conditions	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0021 events1 affected1,862 at risk EG003
Chronic Obstructive Pulmonary Disease	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003
Obstructive Airways Disorder	Respiratory, thoracic and mediastinal disorders	MedDRA (18.0)	Non-systematic Assessment	EG0000 affected1,864 at risk EG0010 affected709 at risk EG0020 affected1,862 at risk EG003

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

ID	Term
D061067	Antibodies, Monoclonal, Humanized
D000911	Antibodies, Monoclonal
D000906	Antibodies
D007136	Immunoglobulins
D007162	Immunoproteins
D001798	Blood Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D012712	Serum Globulins
D005916	Globulins

ID	Title	Description
BG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.
BG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.
BG002	Total	Total of all reporting groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Cohort A: SC Herceptin by Needle/Syringe	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.	242	1,864	1,499	1,864
EG001	Cohort B: SC Herceptin by SID	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.	84	709	576	709
EG002	Cohort A: SC Herceptin by Needle/Syringe Safety Follow-up	Participants received SC Herceptin by an assisted administration as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was taken from a single-use vial and injected by needle/syringe.	202	1,862	0	1,862
EG003	Cohort B: SC Herceptin by SID Safety Follow-up	Participants received SC Herceptin as 600 mg every 3 weeks for a total of 18 doses/cycles. Each dose of SC Herceptin was administered from a pre-filled SID. The first administration was performed by an HCP. Subsequent doses were self-administered by participants who were willing and judged competent by the HCP.	53	707	0	707