Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-003470-40 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This first-in man trial is designed to investigate the safety and tolerability of BI 894416 in healthy male subjects following oral administration of single rising doses.
Pharmacokinetics (PK) including dose proportionality after single dosing of BI 894416 as oral solution will be explored, the investigation of PK of BI 894416 as tablet formulation and the exploration of relative bioavailability of BI 894416 as tablet formulation compared to oral solution.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo matching BI 894416 (SRD Part) | Placebo Comparator | Single Rising Dose (SRD) Part |
|
| BI 894416 3 milligram (mg) | Experimental | SRD Part |
|
| BI 894416 10 mg | Experimental | SRD Part |
|
| BI 894416 20 mg | Experimental | SRD Part |
|
| BI 894416 30 mg | Experimental | SRD Part |
|
| BI 894416 40 mg | Experimental | SRD Part |
|
| BI 894416 54 mg |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BI 894416 | Drug | powder for oral solution |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Drug-related Adverse Events in SRD Part | Percentage of participants with drug-related adverse events (AEs) in SRD part. Percentages are calculated using total number of subjects per treatment as the denominator. Percentages were rounded up to 1 decimal places. | From drug administration until end of the trial, up to 17 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) in SRD Part | Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) in SRD part is presented. | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 168 h after drug administration. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
In addition, the following trial-specific exclusion criteria apply:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Humanpharmakologisches Zentrum Biberach | Biberach | 88397 | Germany |
Not provided
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
For more details refer to:
Not provided
Not provided
Not provided
Not provided
All participants were screened for eligibility to participate in the trial. Participants attended specialized site which would ensure that all participants met all inclusion/exclusion criteria. Participants were not to be entered/randomised to trial treatment if any one of the specific entry criteria were not met.
Single rising dose (SRD) part was designed as single-blind, partially randomized within dose groups, placebo-controlled, parallel-group design and relative bioavailability (rel BA) part was an open-label, randomized two-way crossover followed by a fixed sequence design in healthy volunteers.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Matching BI 894416 (SRD Part) | Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 milliliter (mL) of water after an overnight fast of at least 10 hours (h) in SRD Part. |
| FG001 | BI 894416 3 Milligram (mg) (SRD Part) | Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part. |
| FG002 | BI 894416 10 mg (SRD Part) | Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| FG003 | BI 894416 20 mg (SRD Part) | Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| FG004 | BI 894416 30 mg (SRD Part) | Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| FG005 | BI 894416 40 mg (SRD Part) | Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| FG006 | BI 894416 54 mg (SRD Part) | Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| FG007 | BI 894416 70 mg (SRD Part) | Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| FG008 | BI 894416 10mg tb / 10mg PfOS / 40mg tb | Participants were administered single dose of BI 894416 10 mg tablet (tb) in period 1 followed by BI 894416 10 mg powder for oral solution in period 2 followed by BI 894416 4*10 mg tablets in period 3. Dosages for all periods were administered with 240 mL of water after an overnight fast of at least 10 h. Treatments in period 1 and 2 were separated by a wash-out period of at least 6 days and treatments in periods 2 and 3 were separated by a wash-out period of at least 10 days, in rel BA Part. |
| FG009 | BI 894416 10mg PfOS / 10mg tb / 40mg tb | Participants were administered single dose of BI 894416 10 mg powder for oral solution in period 1 followed by BI 894416 10 mg tablet (tb) in period 2 followed by BI 894416 4*10 mg tablets in period 3. Dosages for all periods were administered with 240 mL of water after an overnight fast of at least 10 h. Treatments in period 1 and 2 were separated by a wash-out period of at least 6 days and treatments in periods 2 and 3 were separated by a wash-out period of at least 10 days, in rel BA Part. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
| |||||||||||||
| Period 3 |
|
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Matching BI 894416 (SRD Part) | Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part. |
| BG001 | BI 894416 3 Milligram (mg) (SRD Part) |
| 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 | Percentage of Participants With Drug-related Adverse Events in SRD Part | Percentage of participants with drug-related adverse events (AEs) in SRD part. Percentages are calculated using total number of subjects per treatment as the denominator. Percentages were rounded up to 1 decimal places. | Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo. | Posted | Number | Percentage of participants | From drug administration until end of the trial, up to 17 days. |
|
For SRD part: From drug administration until end of the trial, up to 17 days. For rel BA part: From drug administration until end of the trial, up to 54 days.
Treated set (TS): This subject set included all subjects who received at least 1 dose of BI 894416 or placebo.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo Matching BI 894416 (SRD Part) | Participants were orally administered single dose of placebo solution matching to BI 894416 with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 25, 2018 | Sep 9, 2022 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 17, 2018 | Sep 9, 2022 | SAP_001.pdf |
Not provided
Not provided
Not provided
Not provided
Not provided
SRD Part |
|
| BI 894416 70 mg | Experimental | SRD Part |
|
| BI 894416 10mg tb / 10mg PfOS / 40mg tb | Experimental | BI 894416 10 mg tablet (tb) / BI 894416 10 mg powder for oral solution (PfOS) / BI 894416 4*10 mg tablets. Relative bioavailability (rel BA) part |
|
| BI 894416 10mg PfOS / 10mg tb / 40mg tb | Experimental | BI 894416 10 mg powder for oral solution (PfOS) / BI 894416 10 mg tablet (tb) / BI 894416 4*10 mg tablets. Relative bioavailability (rel BA) part. |
|
| Placebo | Drug | Oral solution |
|
| BI 894416 | Drug | Tablet |
|
| Maximum Measured Concentration of BI 894416 in Plasma (Cmax) in SRD Part | Maximum measured concentration of BI 894416 in plasma (Cmax) in SRD part is presented. | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 168 h after drug administration. |
| Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) in Rel BA Part | Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) in rel BA part is presented. "BI 894416 40 mg tb" arm was compared in a descriptive fashion with other dose groups without statistical analysis. | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration. |
| Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) in Rel BA Part | Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) in rel BA part is presented. "BI 894416 40 mg tb" arm was compared in a descriptive fashion with other dose groups without statistical analysis. | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration. |
| Maximum Measured Concentration of BI 894416 in Plasma (Cmax) in Rel BA Part | Maximum measured concentration of BI 894416 in plasma (Cmax) in rel BA part is presented. "BI 894416 40 mg tb" arm was compared in a descriptive fashion with other dose groups without statistical analysis. | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration. |
| COMPLETED |
|
| NOT COMPLETED |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part. |
| BG002 | BI 894416 10 mg (SRD Part) | Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| BG003 | BI 894416 20 mg (SRD Part) | Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| BG004 | BI 894416 30 mg (SRD Part) | Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| BG005 | BI 894416 40 mg (SRD Part) | Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| BG006 | BI 894416 54 mg (SRD Part) | Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| BG007 | BI 894416 70 mg (SRD Part) | Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| BG008 | BI 894416 10mg tb / 10mg PfOS / 40mg tb | Participants were administered single dose of BI 894416 10 mg tablet (tb) in period 1 followed by BI 894416 10 mg powder for oral solution in period 2 followed by BI 894416 4*10 mg tablets in period 3. Dosages for all periods were administered with 240 mL of water after an overnight fast of at least 10 h. Treatments in period 1 and 2 were separated by a wash-out period of at least 6 days and treatments in periods 2 and 3 were separated by a wash-out period of at least 10 days, in rel BA Part. |
| BG009 | BI 894416 10mg PfOS / 10mg tb / 40mg tb | Participants were administered single dose of BI 894416 10 mg powder for oral solution in period 1 followed by BI 894416 10 mg tablet (tb) in period 2 followed by BI 894416 4*10 mg tablets in period 3. Dosages for all periods were administered with 240 mL of water after an overnight fast of at least 10 h. Treatments in period 1 and 2 were separated by a wash-out period of at least 6 days and treatments in periods 2 and 3 were separated by a wash-out period of at least 10 days, in rel BA Part. |
| BG010 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BI 894416 3 Milligram (mg) (SRD Part) |
Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part. |
| OG002 | BI 894416 10 mg (SRD Part) | Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| OG003 | BI 894416 20 mg (SRD Part) | Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| OG004 | BI 894416 30 mg (SRD Part) | Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| OG005 | BI 894416 40 mg (SRD Part) | Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| OG006 | BI 894416 54 mg (SRD Part) | Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
| OG007 | BI 894416 70 mg (SRD Part) | Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. |
|
|
| Secondary | Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) in SRD Part | Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) in SRD part is presented. | Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole (nmol) * hour (h) / Litre (L) | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 168 h after drug administration. |
|
|
|
| Secondary | Maximum Measured Concentration of BI 894416 in Plasma (Cmax) in SRD Part | Maximum measured concentration of BI 894416 in plasma (Cmax) in SRD part is presented. | Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole (nmol)/Litre (L) | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24, 34, 48, 72, 96, 168 h after drug administration. |
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 to the Last Quantifiable Data Point (AUC0-tz) in Rel BA Part | Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz) in rel BA part is presented. "BI 894416 40 mg tb" arm was compared in a descriptive fashion with other dose groups without statistical analysis. | Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole (nmol) * hour (h)/Litre (L) | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration. |
|
|
|
|
| Secondary | Area Under the Concentration-time Curve of BI 894416 in Plasma Over the Time Interval From 0 Extrapolated to Infinity (AUC0-inf) in Rel BA Part | Area under the concentration-time curve of BI 894416 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf) in rel BA part is presented. "BI 894416 40 mg tb" arm was compared in a descriptive fashion with other dose groups without statistical analysis. | Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole (nmol) * hour (h)/Litre (L) | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration. |
|
|
|
|
| Secondary | Maximum Measured Concentration of BI 894416 in Plasma (Cmax) in Rel BA Part | Maximum measured concentration of BI 894416 in plasma (Cmax) in rel BA part is presented. "BI 894416 40 mg tb" arm was compared in a descriptive fashion with other dose groups without statistical analysis. | Pharmacokinetic (PK) parameter analysis set (PKS): This subject set included all subjects of the treated set who provided at least 1 PK parameter that was not excluded because of an important protocol deviation relevant to the statistical evaluation of PK endpoints or due to PK non-evaluability. | Posted | Geometric Mean | Geometric Coefficient of Variation | nanomole (nmol)/Litre (L) | Pharmacokinetic samples were collected at 2 hours (h) prior drug administration and at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 h after drug administration. |
|
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 3 |
| 14 |
| EG001 | BI 894416 3 Milligram (mg) (SRD Part) | Participants were administered single dose of BI 894416 3 milligram (mg) powder for oral solution (PfOS) with 240 mL of water after an overnight fast of at least 10 hours (h) in SRD Part. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | BI 894416 10 mg (SRD Part) | Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | BI 894416 20 mg (SRD Part) | Participants were administered single dose of BI 894416 20 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. | 0 | 6 | 0 | 6 | 5 | 6 |
| EG004 | BI 894416 30 mg (SRD Part) | Participants were administered single dose of BI 894416 30 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG005 | BI 894416 40 mg (SRD Part) | Participants were administered single dose of BI 894416 40 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG006 | BI 894416 54 mg (SRD Part) | Participants were administered single dose of BI 894416 54 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG007 | BI 894416 70 mg (SRD Part) | Participants were administered single dose of BI 894416 70 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in SRD Part. | 0 | 6 | 0 | 6 | 2 | 6 |
| EG008 | BI 894416 10 mg PfOS (R) | Participants were administered single dose of BI 894416 10 mg powder for oral solution with 240 mL of water after an overnight fast of at least 10 h in rel BA part. | 0 | 12 | 0 | 12 | 4 | 12 |
| EG009 | BI 894416 10 mg tb (T) | Participants were administered single dose of BI 894416 10 mg tablet with 240 mL of water after an overnight fast of at least 10 h in rel BA part. | 0 | 12 | 0 | 12 | 3 | 12 |
| EG010 | BI 894416 40 mg tb | Participants were administered single dose of BI 894416 4*10 mg tablets with 240 mL of water after an overnight fast of at least 10 h in rel BA part. | 0 | 12 | 0 | 12 | 4 | 12 |
| Abdominal pain | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Salivary hypersecretion | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oral mucosal eruption | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oral papule | Gastrointestinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 21.0 | Systematic Assessment |
|
| Conjunctivitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Respiratory tract infection | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 21.0 | Systematic Assessment |
|
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Contusion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA 21.0 | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 21.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 21.0 | Systematic Assessment |
|
| Ocular discomfort | Eye disorders | MedDRA 21.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MedDRA 21.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided