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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004941-27 | EudraCT Number |
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The purpose of this study is to evaluate the efficacy of ABT-888 in combination with temozolomide versus temozolomide alone in subjects with metastatic melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo for ABT-888 BID + TMZ QD | Placebo Comparator | Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
|
| ABT-888 20 mg BID + TMZ QD | Active Comparator | ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
|
| ABT-888 40 mg BID + TMZ QD | Active Comparator | ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| temozolomide | Drug | temozolomide capsule administered orally once daily for 5 days every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS): Time to Event | PFS: the number of days from the date that the participant was randomized to the date the participant experienced a confirmed event of disease progression (radiological, as determined by the central imaging center; or clinical, as determined by the investigator), or to the date of death (all causes of mortality) if disease progression was not reached. All events were included whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced a confirmed event of disease progression, provided the death occurred within 8 weeks of the last available disease progression assessment. The distribution of PFS, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the quartiles for the PFS distribution are provided. | Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS): Time to Event | OS was defined as the number of days from the date the participant was randomized to the date of death. All deaths were included, whether the participant was still taking or had discontinued study drug. If a participant had not died and was lost to follow-up, then data were censored at the last study visit or contact date, or date the participant was last known to be alive, whichever was later; if the participant was not lost to follow-up, then data were censored at the last study visit or contact date, whichever was later. The distribution of OS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the OS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AbbVie Inc | AbbVie | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26202595 | Result | Middleton MR, Friedlander P, Hamid O, Daud A, Plummer R, Falotico N, Chyla B, Jiang F, McKeegan E, Mostafa NM, Zhu M, Qian J, McKee M, Luo Y, Giranda VL, McArthur GA. Randomized phase II study evaluating veliparib (ABT-888) with temozolomide in patients with metastatic melanoma. Ann Oncol. 2015 Oct;26(10):2173-9. doi: 10.1093/annonc/mdv308. Epub 2015 Jul 22. |
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A total of 346 subjects were randomized; 2 subjects did not receive study drug and were excluded from the safety analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo for ABT-888 BID + TMZ QD | Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
| FG001 | ABT-888 20 mg BID + TMZ QD | ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
| FG002 | ABT-888 40 mg BID + TMZ QD | ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
ITT population defined as all randomized participants.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo for ABT-888 BID + TMZ QD | Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
| BG001 | ABT-888 20 mg BID + TMZ QD |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Progression-Free Survival (PFS): Time to Event | PFS: the number of days from the date that the participant was randomized to the date the participant experienced a confirmed event of disease progression (radiological, as determined by the central imaging center; or clinical, as determined by the investigator), or to the date of death (all causes of mortality) if disease progression was not reached. All events were included whether the participant was still taking or had discontinued study drug. Events of death were included for participants who had not experienced a confirmed event of disease progression, provided the death occurred within 8 weeks of the last available disease progression assessment. The distribution of PFS, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% confidence intervals (95% CIs) for the quartiles for the PFS distribution are provided. | ITT population defined as all randomized participants. | Posted | Number | 95% Confidence Interval | days | Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
Treatment-emergent AEs (TEAEs) were collected from first dose of study drug until 30 days after the last dose of study drug (up to 5.6 years); SAEs were collected from the time informed consent was obtained (up to 5.7 years).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo for ABT-888 BID + TMZ QD | Placebo for ABT-888 twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Information | AbbVie | 800-633-9110 |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077204 | Temozolomide |
| C521013 | veliparib |
| ID | Term |
|---|---|
| D003606 | Dacarbazine |
| D014226 | Triazenes |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
Not provided
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|
| ABT-888 | Drug | ABT-888 capsule administered orally twice daily for 7 days every 28 days |
|
|
| Placebo | Other | Placebo for ABT-888 capsule administered orally twice daily for 7 days every 28 days |
|
| Per protocol, survival follow-up information was to be obtained every 3 months for up to 18 months after the final visit for the subject. The maximum observed follow-up at the overall survival analysis time was 21.0 months. |
| 12-Month Overall Survival (OS) Rate | The 12-month overall survival rate was defined as the percentage of participants surviving at 12 months. The distribution of 12-month OS rate was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | Per protocol, survival was to be assessed every 4 weeks or as needed after participant is registered as off-study for up to 18 months. The maximum observed follow-up at the overall survival analysis time was 21.0 months. |
| 6-month Progression-Free Survival Rate | The 6-month progression-free survival rate was defined as the percentage of participants without disease progression at 6 months.The distribution of 6-month progression-free survival rate, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
| Objective Response Rate | The objective response rate was defined as the percentage of participants with a confirmed CR or PR per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography (CT) scan: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
| Time to Disease Progression | The distribution of time to disease progression, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | Every Cycle (28 Days), until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
| Disease Control Rate | The disease control rate was defined as the percentage of participants who had at least stable disease (complete response, partial response, or stable disease) through the end of Week 8. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | Week 8 |
| Time to Neurological/Brain Metastases Progression | Time to neurological/brain metastases progression, defined as the number of days from the date of randomization to the date the participant experienced an event of neurological/brain metastases progression, was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the distribution are provided. All events of progression were included, regardless of whether the event occurred while the participant was still taking study drug. If a participant did not experience an event, data were censored at the date of the last available brain CT scan. For participants with no postbaseline brain CT scans, data were censored at randomization. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days.
| BG002 | ABT-888 40 mg BID + TMZ QD | ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
|
|
|
|
| Secondary | Overall Survival (OS): Time to Event | OS was defined as the number of days from the date the participant was randomized to the date of death. All deaths were included, whether the participant was still taking or had discontinued study drug. If a participant had not died and was lost to follow-up, then data were censored at the last study visit or contact date, or date the participant was last known to be alive, whichever was later; if the participant was not lost to follow-up, then data were censored at the last study visit or contact date, whichever was later. The distribution of OS was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the OS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints. | ITT population defined as all randomized participants. | Posted | Number | 95% Confidence Interval | days | Per protocol, survival follow-up information was to be obtained every 3 months for up to 18 months after the final visit for the subject. The maximum observed follow-up at the overall survival analysis time was 21.0 months. |
|
|
|
| Secondary | 12-Month Overall Survival (OS) Rate | The 12-month overall survival rate was defined as the percentage of participants surviving at 12 months. The distribution of 12-month OS rate was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | ITT population defined as all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Per protocol, survival was to be assessed every 4 weeks or as needed after participant is registered as off-study for up to 18 months. The maximum observed follow-up at the overall survival analysis time was 21.0 months. |
|
|
|
| Secondary | 6-month Progression-Free Survival Rate | The 6-month progression-free survival rate was defined as the percentage of participants without disease progression at 6 months.The distribution of 6-month progression-free survival rate, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | ITT population defined as all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Every Cycle (28 Days) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
|
|
|
| Secondary | Objective Response Rate | The objective response rate was defined as the percentage of participants with a confirmed CR or PR per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by computed tomography (CT) scan: complete response (CR), disappearance of all target lesions; partial response (PR), ≥30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | All subjects in the ITT population (defined as all randomized participants) with measurable disease. | Posted | Number | 95% Confidence Interval | percentage of participants | Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
|
|
|
| Secondary | Time to Disease Progression | The distribution of time to disease progression, as determined by the central imaging center (radiological)/ investigator (clinical), was estimated for each treatment group using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the PFS distribution are provided. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | ITT population defined as all randomized participants. | Posted | Number | 95% Confidence Interval | days | Every Cycle (28 Days), until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
|
|
|
| Secondary | Disease Control Rate | The disease control rate was defined as the percentage of participants who had at least stable disease (complete response, partial response, or stable disease) through the end of Week 8. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ treatment groups were statistically significantly better than the Placebo + TMZ treatment group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | ITT population defined as all randomized participants. | Posted | Number | 95% Confidence Interval | percentage of participants | Week 8 |
|
|
|
| Secondary | Time to Neurological/Brain Metastases Progression | Time to neurological/brain metastases progression, defined as the number of days from the date of randomization to the date the participant experienced an event of neurological/brain metastases progression, was estimated using Kaplan-Meier methodology. Point estimates and 95% CIs for the quartiles for the distribution are provided. All events of progression were included, regardless of whether the event occurred while the participant was still taking study drug. If a participant did not experience an event, data were censored at the date of the last available brain CT scan. For participants with no postbaseline brain CT scans, data were censored at randomization. Per protocol, because neither the ABT-888 20 mg BID + TMZ nor ABT-888 40 mg BID + TMZ groups were statistically significantly better than the Placebo + TMZ group for the primary endpoint of PFS, confirmatory statistical testing was not continued for any secondary endpoints, regardless of the observed P values. | ITT population defined as all randomized participants. | Posted | Number | 95% Confidence Interval | days | Every 2 cycles (8 weeks) until disease progression was observed or another reason for discontinuation of assessments was identified by the investigator. The maximum observed followup duration at the progression-free survival analysis time was 9.7 months. |
|
|
|
| 28 |
| 113 |
| 112 |
| 113 |
| EG001 | ABT-888 20 mg BID + TMZ QD | ABT-888 20 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. | 27 | 116 | 116 | 116 |
| EG002 | ABT-888 40 mg BID + TMZ QD | ABT-888 40 mg twice daily (BID) for 7 days every 28 days plus temozolomide (TMZ; by body surface area) 150 mg/m2 once daily (QD) for 5 days every 28 days. | 31 | 115 | 113 | 115 |
| BONE MARROW FAILURE | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| FEBRILE NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| PANCYTOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| ANGINA PECTORIS | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| ARRHYTHMIA | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| CARDIAC FAILURE CONGESTIVE | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| PERICARDIAL EFFUSION | Cardiac disorders | MedDRA (17.1) | Systematic Assessment |
|
| ADRENAL INSUFFICIENCY | Endocrine disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| GASTRIC HAEMORRHAGE | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| HAEMATOCHEZIA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| MELAENA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| MOUTH SWELLING | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| SMALL INTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| SMALL INTESTINAL OBSTRUCTION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| UPPER GASTROINTESTINAL HAEMORRHAGE | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DEATH | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| DISEASE PROGRESSION | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| PAIN | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| CHOLANGITIS | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| CHOLECYSTITIS ACUTE | Hepatobiliary disorders | MedDRA (17.1) | Systematic Assessment |
|
| APPENDICITIS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| BRONCHITIS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| CELLULITIS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| LOCALISED INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| LOWER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| PNEUMONIA | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| POST PROCEDURAL INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| SEPSIS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| ALLERGIC TRANSFUSION REACTION | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| LIMB CRUSHING INJURY | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| RADIUS FRACTURE | Injury, poisoning and procedural complications | MedDRA (17.1) | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| DEHYDRATION | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| NECK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| PATHOLOGICAL FRACTURE | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| GLIOSARCOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| MALIGNANT NEOPLASM PROGRESSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| MALIGNANT PLEURAL EFFUSION | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| METASTASES TO BONE | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| METASTATIC MALIGNANT MELANOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| METASTATIC PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| OESOPHAGEAL ADENOCARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| APHASIA | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| ATAXIA | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| CEREBROVASCULAR ACCIDENT | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| HAEMORRHAGE INTRACRANIAL | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| NEUROPATHY PERIPHERAL | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| SPINAL CORD COMPRESSION | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| SYNCOPE | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| TREMOR | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| CONFUSIONAL STATE | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| HAEMATURIA | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| NEPHROLITHIASIS | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| RENAL FAILURE ACUTE | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| URETHRAL PROLAPSE | Renal and urinary disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| HAEMOTHORAX | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| PLEURAL EFFUSION | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| PULMONARY ARTERY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| PULMONARY EMBOLISM | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| PULMONARY THROMBOSIS | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DEEP VEIN THROMBOSIS | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPOTENSION | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| ORTHOSTATIC HYPOTENSION | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| PELVIC VENOUS THROMBOSIS | Vascular disorders | MedDRA (17.1) | Systematic Assessment |
|
| LEUKOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| LYMPHOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| NEUTROPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| THROMBOCYTOPENIA | Blood and lymphatic system disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| ABDOMINAL PAIN UPPER | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| CONSTIPATION | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DIARRHOEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DRY MOUTH | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSPEPSIA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| GASTROOESOPHAGEAL REFLUX DISEASE | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| NAUSEA | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| VOMITING | Gastrointestinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| CHEST PAIN | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| CHILLS | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| FATIGUE | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| INFLUENZA LIKE ILLNESS | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| OEDEMA PERIPHERAL | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| PAIN | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| PYREXIA | General disorders | MedDRA (17.1) | Systematic Assessment |
|
| SINUSITIS | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA (17.1) | Systematic Assessment |
|
| HAEMOGLOBIN DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| PLATELET COUNT DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| WEIGHT DECREASED | Investigations | MedDRA (17.1) | Systematic Assessment |
|
| DECREASED APPETITE | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPERGLYCAEMIA | Metabolism and nutrition disorders | MedDRA (17.1) | Systematic Assessment |
|
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| GROIN PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MUSCULOSKELETAL CHEST PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MUSCULOSKELETAL PAIN | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| MYALGIA | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| CANCER PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| TUMOUR PAIN | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (17.1) | Systematic Assessment |
|
| DIZZINESS | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSGEUSIA | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| HEADACHE | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| LETHARGY | Nervous system disorders | MedDRA (17.1) | Systematic Assessment |
|
| ANXIETY | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| INSOMNIA | Psychiatric disorders | MedDRA (17.1) | Systematic Assessment |
|
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DYSPNOEA | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA (17.1) | Systematic Assessment |
|
| DRY SKIN | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| ERYTHEMA | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| HYPERHIDROSIS | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| NIGHT SWEATS | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| PRURITUS | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
| RASH | Skin and subcutaneous tissue disorders | MedDRA (17.1) | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
|
| 75th percentile |
|
|
| 75th percentile |
|
| 50th percentile |
|
| 75th percentile |
|