Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2025-12-25 @ 5:20 PM
NCT ID:
NCT05580003
Description:
Safety population included all participants randomly assigned to study intervention, who took at least 1 dose of study intervention. Participants were analyzed according to the product they actually received.
Frequency Threshold:
5
Time Frame:
Part 1 and Part 6: From start of study treatment up to 28-35 days after administration of last dose of study intervention (maximum up to 48 and 52 days respectively); Part 2 and Part 5: From start of study treatment up to 38-45 days after administration of last dose of study intervention (maximum up to 55 and 65 days respectively); Part 3 and Part 4: From start of study treatment up to 29-36 days after administration of last dose of study intervention (maximum up to 49 and 47 days respectively)
Study:
NCT05580003
Study Brief:
A Study to Learn Safety and Blood Levels of PF-07817883 in Healthy People
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Part 1: Placebo (Suspension), Fed | Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included. | 0 | None | 0 | 2 | 1 | 2 | View |
| Part 1: PF-07817883 150 mg (Suspension), Fasted | Participants who received a single dose of PF-07817883 150 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 1: PF-07817883 500 mg (Suspension), Fasted | Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 1: PF-07817883 500 mg (Suspension), Fed | Participants who received a single dose of PF-07817883 500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fed conditions were included. | 0 | None | 0 | 4 | 0 | 4 | View |
| Part 1: PF-07817883 1500 mg (Suspension), Fasted | Participants who received a single dose of PF-07817883 1500 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included. | 0 | None | 0 | 6 | 3 | 6 | View |
| Part 1: PF-07817883 3000 mg (Suspension), Fasted | Participants who received a single dose of PF-07817883 3000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included. | 0 | None | 0 | 5 | 0 | 5 | View |
| Part 1: PF-07817883 4000 mg (Suspension), Fasted | Participants who received a single dose of PF-07817883 4000 mg as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included. | 0 | None | 0 | 5 | 1 | 5 | View |
| Part 2: Placebo (Suspension) BID, Fasted | Participants received placebo oral suspension twice a day (BID) administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 2: PF-07817883 200 mg (Suspension) BID, Fasted | Participants received PF-07817883 200 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 200 mg in the morning under fasted conditions. | 0 | None | 0 | 4 | 1 | 4 | View |
| Part 2: PF-07817883 600 mg (Suspension) BID, Fasted | Participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions. | 0 | None | 0 | 4 | 0 | 4 | View |
| Part 2: PF-07817883 1500 mg (Suspension) BID, Fasted | Participants received PF-07817883 1500 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 1500 mg in the morning under fasted conditions. | 0 | None | 0 | 4 | 2 | 4 | View |
| Part 2: Placebo (Suspension) BID, Fasted, Chinese | Chinese participants received placebo oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of placebo in the morning under fasted conditions. | 0 | None | 0 | 1 | 0 | 1 | View |
| Part 2: PF-07817883 600 mg (Suspension) BID, Fasted, Chinese | Chinese participants received PF-07817883 600 mg oral suspension BID administered every 12 hours on Days 1 to 9. On Day 10, participants received only one dose of PF-07817883 600 mg in the morning under fasted conditions. | 0 | None | 0 | 3 | 2 | 3 | View |
| Part 3: PF-07817883 600 mg (Suspension), Fasted | Participants received a single dose of PF-07817883 600 mg oral suspension under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required. | 0 | None | 0 | 12 | 4 | 12 | View |
| Part 3: PF-07817883 SDD 600 mg (Tablet), Fasted | Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required. | 0 | None | 0 | 12 | 1 | 12 | View |
| Part 3: PF-07817883 SDD 600 mg (Tablet), Fed | Participants received a single dose of PF-07817883 600 mg spray dried dispersion (SDD) under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack. | 0 | None | 0 | 6 | 1 | 6 | View |
| Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fasted | Participants received a single dose of PF-07817883 600 mg crystalline tablet under fasted conditions on Day 1 of either Period 1, 2, 3 or 4. An overnight fast for approximately 10 hours was required. | 0 | None | 0 | 12 | 4 | 12 | View |
| Part 3: PF-07817883 Crystalline 600 mg (Tablet), Fed | Participants received a single dose of PF-07817883 600 mg crystalline tablet under fed conditions on Day 1 of either Period 1, 2, 3 or 4. PF-07817883 was administered approximately 10 minutes after finishing the meal/snack. | 0 | None | 0 | 6 | 2 | 6 | View |
| Part 5: PF-07817883 600 mg (Suspension) BID/ Midazolam 5 mg | Participants received PF-07817883 600 mg oral suspension twice a day (BID) for 10 days (Day 1 morning to Day 10 morning). On Day 10 morning, participants received a single oral dose of 5 mg midazolam administered with PF-07817883. | 0 | None | 0 | 13 | 11 | 13 | View |
| Part 5: Midazolam 5 mg | Participants received oral solution of Midazolam 5 mg on Day 1 of either Period 1 or 2. | 0 | None | 0 | 13 | 10 | 13 | View |
| Part 6: PF-07817883 6000 mg (Suspension), Fasted | Participants received 6000 mg PF-07817883 oral suspension administered as two split doses of 3000 mg at 0 and 1 hour on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours. | 0 | None | 0 | 23 | 0 | 23 | View |
| Part 6: Moxifloxacin 400 mg, Fasted | Participants received 400 mg Moxifloxacin oral tablet and placebo at 0 and 1 hour respectively on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours. | 0 | None | 0 | 24 | 0 | 24 | View |
| Part 1: Placebo (Suspension), Fasted | Participants who received a single dose of placebo as an oral suspension on Day 1 of either Period 1, 2 or 3 under fasted conditions were included. | 0 | None | 0 | 10 | 4 | 10 | View |
| Part 4: PF-07817883 600 mg (Suspension), Fasted | Participants received a single dose of PF-07817883 600 mg oral suspension on Day 1 following an overnight fast of approximately 10 hours. | 0 | None | 0 | 6 | 4 | 6 | View |
| Part 6: Placebo (Suspension), Fasted | Participants received Placebo oral suspension at 0 and 1 hours on Day 1 of either Period 1, 2 or 3 following an overnight fast of at least 10 hours. | 0 | None | 0 | 23 | 0 | 23 | View |
Serious Events(If Any):
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Constipation | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Diarrhea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Flatulence | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| COVID-19 | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.0 | View |
| Nasopharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.0 | View |
| Upper respiratory tract infection | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.0 | View |
| Lipase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.0 | View |
| Urine output decreased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.0 | View |
| Muscle spasms | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | View |
| Headache | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.0 | View |
| Defaecation urgency | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Glossodynia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Nausea | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Vomiting | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Vessel puncture site bruise | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.0 | View |
| Oral herpes | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.0 | View |
| Pharyngitis | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.0 | View |
| Skin laceration | NON_SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA v26.0 | View |
| Alanine aminotransferase increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.0 | View |
| Hypoaesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.0 | View |
| Urinary retention | NON_SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | MedDRA v26.0 | View |
| Rhinorrhoea | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | View |
| Pseudofolliculitis | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.0 | View |
| Haematoma | NON_SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA v26.0 | View |
| Abdominal distension | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Haematochezia | NON_SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA v26.0 | View |
| Fatigue | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.0 | View |
| Gastroenteritis viral | NON_SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA v26.0 | View |
| Dysmenorrhoea | NON_SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA v26.0 | View |
| Cough | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | View |
| Asthenia | NON_SYSTEMATIC_ASSESSMENT | General disorders | MedDRA v26.0 | View |
| Urine output increased | NON_SYSTEMATIC_ASSESSMENT | Investigations | MedDRA v26.0 | View |
| Syncope | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.0 | View |
| Myalgia | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | View |
| Pain in extremity | NON_SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA v26.0 | View |
| Dizziness | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.0 | View |
| Paraesthesia | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.0 | View |
| Somnolence | NON_SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA v26.0 | View |
| Haemoptysis | NON_SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA v26.0 | View |
| Pruritus | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.0 | View |
| Urticaria | NON_SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | MedDRA v26.0 | View |