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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005518-20 | EudraCT Number | EudraCT |
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To investigate the effect of steady-state itraconazole on the pharmacokinetics of steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of rosuvastatin
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Faldaprevir + Itraconazole | Experimental | Interaction of Faldaprevir and Itraconazole |
|
| Part 2:Faldaprevir+Rosuvastatin+Atorvast | Experimental | Interaction of Faldaprevir, Rosuvastatin and Atorvastatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Itraconazole | Drug | twice daily |
| |
| Atorvastatin |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss (Itraconazole Part) | Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval Ï„ (AUCÏ„,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods |
| Cmax,ss (Itraconazole Part) | Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods. |
| AUC0-∞ of Atorvastatin (Statins Part) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods. |
| Cmax of Atorvastatin (Statins Part) | Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods |
| Measure | Description | Time Frame |
|---|---|---|
| AUCÏ„,ss of Faldaprevir (Statins Part) | Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval Ï„ (AUCÏ„,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence. |
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Inclusion criteria:
1. Healthy male and female subjects
Exclusion criteria:
1. Any relevant deviation from healthy conditions
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| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1220.61.1 Boehringer Ingelheim Investigational Site | Ingelheim | Germany |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment Sequence A_B (Itraconazole Part) | The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part. Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total). Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total). Treatment A directly preceded treatment B, without an intermittent washout period. Oral administration with 240 mL water. |
| FG001 | Treatment Sequence C_D (Statins Part) | The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part. Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1. Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1. Treatment C preceded treatment D. Oral administration with 240 mL water. |
| FG002 | Treatment Sequence E_F (Statins Part) | The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part. Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1. Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1. Treatment E preceded treatment F. Oral administration with 240 mL water. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The itraconazole part of this trial was done open-label with a fixed-sequence, 2-period design (treatment seq. A_B).
The statins part was done open-label with a fixed-sequence, 2-period design. Subjects in the statins part were assigned to 1 of the 2 possible treatment sequences: treatment seq. C_D or E_F.
Both parts were performed independently.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence A_B (Itraconazole Part) | The itraconazole part (interaction of steady state faldaprevir with itraconazole) of this trial was done open-label with a fixed-sequence, 2-period design; performed independently from the statins part. Treatment A: Faldaprevir (120 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 1 (6 days in total). Treatment B: Faldaprevir (120 mg) was given once daily from Day -3 to Day 1 (4 days). In addition, itraconazole (200 mg) was given twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total). Treatment A directly preceded treatment B, without an intermittent washout period. Oral administration with 240 mL water. |
| 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 | AUCÏ„,ss (Itraconazole Part) | Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval Ï„ (AUCÏ„,ss) of faldaprevir. Outcome measure for the itraconazole part (treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | pharmacokinetic (PK) set of the itraconazole part of this trial. The PK set included all treated subjects of the itraconazole part that provided at least 1 observation for at least 1 primary endpoint without important protocal violations with respect to the statistical evaluation of the PK endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h (hours) after administration of faldaprevir on Day 1 of both periods |
|
Adverse events were to be recorded from screening until the end-of-trial examination. Itraconazole part: up to 25 days. Statins part: up to 33 days.
Adverse events were recorded throughout the clinical trial, but were specifically asked for at prespecified time points and additionally whenever the investigator deemed necessary. Subjects were asked to spontaneously report any adverse events as well as the time of onset, end, and intensity.
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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 | Faldaprevir (Itraconazole Part) | Faldaprevir: 120 mg once daily with a 120 mg twice daily loading dose on Day -5. Treatment A. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D000069059 | Atorvastatin |
| C552340 | faldaprevir |
| D000068718 | Rosuvastatin Calcium |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
single dose |
|
| Faldaprevir | Drug | once daily |
|
| Rosuvastatin | Drug | single dose |
|
| Faldaprevir | Drug | once daily |
|
| AUC0-∞ of Rosuvastatin (Statins Part) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods |
| Cmax of Rosuvastatin | Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods |
| Cmax,ss of Faldaprevir (Statins Part) | Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence. |
| AUC0-tz of Atorvastatin | Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods |
| AUC0-tz of Rosuvastatin | Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods |
| BG001 | Treatment Sequence C_D (Statins Part) | The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part. Treatment C: Atorvastatin (10 mg) was given as a single dose on Day 1. Treatment D: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, atorvastatin (10 mg) was given as a single dose on Day 1. Treatment C preceded treatment D. Oral administration with 240 mL water. |
| BG002 | Treatment Sequence E_F (Statins Part) | The statins part (interaction of multiple dose faldaprevir with either atorvastatin or rosuvastatin) was done open-label with a fixed-sequence, 2-period design; performed independently from the itraconazole part. Treatment E: Rosuvastatin (10 mg) was given as a single dose on Day 1. Treatment F: Faldaprevir (240 mg) was given twice daily on Day -5 and once daily from Day -4 to Day 2 (7 days in total). In addition, rosuvastatin (10 mg) was given as a single dose on Day 1. Treatment E preceded treatment F. Oral administration with 240 mL water. |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
Faldaprevir 120 mg once daily from Day -4 to Day 1 with a 120 mg twice daily loading dose on Day -5 (6 days in total).
Treatment A.
| OG001 | Faldaprevir+Itraconazole | Faldaprevir 120 mg once daily from Day -3 to Day 1 + itraconazole 200 mg twice daily on Day -3 and once daily from Day -2 to Day 1 (4 days in total). Treatment B. |
|
|
|
| Primary | Cmax,ss (Itraconazole Part) | Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the itraconazole part (Treatment sequence A_B) of this trial. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set of the itraconazole part of this trial. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00 h after administration of faldaprevir on Day 1 of both periods. |
|
|
|
|
| Primary | AUC0-∞ of Atorvastatin (Statins Part) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of atorvastatin after single dose administration. Outcome measure for the statins part of this trial, treatment sequence C_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set of the statins part and assigned to atorvastatin (treatment sequence C_D). Pharmacokinetic set (PK set): all treated subjects of the statins part that provided at least 1 observation for at least 1 primary endpoint without important protocol violations with respect to the statistical evaluation of the pharmacokinetic endpoints. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods. |
|
|
|
|
| Primary | Cmax of Atorvastatin (Statins Part) | Maximum measured concentration of the analyte in plasma of atorvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence C_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set of the statins part and assigned to atorvastatin (treatment sequence C_D). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods |
|
|
|
|
| Secondary | AUCÏ„,ss of Faldaprevir (Statins Part) | Area under the concentration-time curve of the analyte in plasma at steady state over the dosing interval Ï„ (AUCÏ„,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F. | PK set of the statins part. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence. |
|
|
|
| Secondary | Cmax,ss of Faldaprevir (Statins Part) | Maximum measured concentration of the analyte in plasma at steady state over the dosing interval (Cmax,ss) of faldaprevir. Outcome measure for the statins part of this trial, treatment sequences C_D and E_F. | PK set of the statins part. | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin/atorvastatin on Day 1 of the second periods of each treatment sequence. |
|
|
|
| Secondary | AUC0-tz of Atorvastatin | Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of atorvastatin. Outcome measure for the statins part of this trial, treatment sequence C_D. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set of the statins part and assigned to atorvastatin (treatment sequence C_D). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of atorvastatin on Day 1 of both periods |
|
|
|
|
| Primary | AUC0-∞ of Rosuvastatin (Statins Part) | Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞) of rosuvastatin after single dose administration of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods |
|
|
|
|
| Primary | Cmax of Rosuvastatin | Maximum measured concentration of the analyte in plasma of rosuvastatin (Cmax). Outcome measure for the statins part of this trial, treatment sequence E_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods |
|
|
|
|
| Secondary | AUC0-tz of Rosuvastatin | Area under the plasma concentration-time curve of the analyte over the time interval from 0 to the time tz of the last measurable concentration (AUC0-tz) of rosuvastatin. Outcome measure for the statins part of this trial, treatment sequence E_F. The measured values show inter-individual variabilities, whereas the statistical analyses show intra-individual variabilities. | PK set of the statins part and assigned to rosuvastatin (treatment sequence E_F). | Posted | Geometric Mean | Geometric Coefficient of Variation | ng*h/mL | -1:30, 0:30, 1:00, 1:30, 2:00, 3:00, 4:00, 6:00, 8:00, 10:00, 11:00, 12:00, 24:00, 36:00, 48:00, 60:00 h after administration of rosuvastatin on Day 1 of both periods |
|
|
|
|
| 0 |
| 18 |
| 13 |
| 18 |
| EG001 | Faldaprevir+Itraconazole (Itraconazole Part) | Faldaprevir: 120 mg once daily. Itraconazole: 200 mg once daily with a 200 mg twice daily loading dose on Day -3. Treatment B. | 0 | 17 | 3 | 17 |
| EG002 | Atorvastatin (Statins Part) | Atorvastatin: 10 mg was given as a single dose on Day 1. Treatment C. From the time of the single dose atorvastatin administration in treatment C until the time of the first faldaprevir administration in treatment D or until 1 day after the trial completion date of the respective subject. | 0 | 16 | 5 | 16 |
| EG003 | Rosuvastatin (Statins Part) | Rosuvastatin: 10 mg was given as a single dose on Day 1. Treatment E. From the time of the single dose rosuvastatin administration in treatment E until the time of the first faldaprevir administration in treatment F or until 1 day after the trial completion date. | 0 | 17 | 4 | 17 |
| EG004 | Faldaprevir (Statins Part) | From the time of the first faldaprevir administration in treatment D or F until the combined administration of faldaprevir with atorvastatin or rosuvastatin in treatment D or F, respectively, or until 1 day after the trial completion date. | 0 | 32 | 23 | 32 |
| EG005 | Faldaprevir + Atorvastatin (Statins Part) | Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Atorvastatin: 10 mg was given as a single dose on Day 1. Treatment D. From the time of the combined administration of faldaprevir with atorvastatin in treatment D until 1 day after the trial completion date. | 0 | 15 | 8 | 15 |
| EG006 | Faldaprevir + Rosuvastatin (Statins Part) | Faldaprevir: 240 mg was given twice daily on Day -5 and once daily from Day -4 to Day 2. Rosuvastatin: 10 mg was given as a single dose on Day 1. Treatment F. From the time of the combined administration of faldaprevir with rosuvastatin in treatment F until 1 day after the trial completion date. | 0 | 17 | 9 | 17 |
| Rhinitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MEDDRA 16.0 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Headache | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Ocular icterus | Eye disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Palpitations | Cardiac disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Haematoma | Vascular disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Flatulence | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Jaundice | Hepatobiliary disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Fatigue | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Thirst | General disorders | MEDDRA 16.0 | Systematic Assessment |
|
| Sunburn | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
|
| Hand fracture | Injury, poisoning and procedural complications | MEDDRA 16.0 | Systematic Assessment |
|
Not provided
Not provided
Not provided
| D010879 |
| Piperazines |
| D011758 | Pyrroles |
| D006538 | Heptanoic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |