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 @ 3:37 PM
Ignite Modification Date:
2025-12-25 @ 1:49 PM
NCT ID:
NCT00662792
Description:
Treated Set (TS): All randomised patients who took at least one dose of study medication.
Frequency Threshold:
5
Time Frame:
From first drug administration until last drug administration (average duration of 42 days) + 30 days, up to 91 days for T+S_PE, up to 98 days for Tio18GEL, up 89 days for Salm50DPI and up to 113 days for T18GEL+S_DPI.
Study:
NCT00662792
Study Brief:
Efficacy and Safety Comparison of Tiotropium Daily + Salmeterol Daily or Twice Daily Versus Tiotropium Daily in Patients With COPD
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| 18 µg Tiotropium (Tio18GEL) | 18 µg Tiotropium (Tio18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® QD in the morning, one capsule of matching placebo via the blue HandiHaler® and one actuation from the placebo MDPI in the morning and one actuation from the placebo MDPI in the evening. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods. | 1 | None | 7 | 135 | 15 | 135 | View |
| 18 µg Tiotropium Free Combination (T18GEL+S_DPI) | 18 µg Tiotropium (T18GEL) inhalation powder from one capsule via the grey Spiriva HandyHaler® in the morning plus one actuation of 50 µg Salmeterol MDPI (S\_DPI) BID, in the morning and in the evening, and one placebo capsule from blue Handi Haler® in the morning. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods. | 0 | None | 2 | 132 | 11 | 132 | View |
| Total Treated | All patients who received at least one dose of study medication. | 1 | None | 13 | 146 | 47 | 146 | View |
| 7.5 µg /25 µg Tio /Salmeterol (T+S_PE) | Fixed-dose combination of 7.5 µg/ 25 µg Tiotropium/Salmeterol (T+S\_PE) inhalation powder from one capsule via the blue HandiHaler® once daily (QD) in the morning, one capsule of matching placebo via the grey HandiHaler® and one actuation from the placebo Multi-Dose Powder Inhaler (MDPI) in the morning and one actuation from the placebo MDPI in the evening. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods. | 0 | None | 1 | 132 | 14 | 132 | View |
| 50 µg Salmeterol MDPI (Salm50DPI) | One actuation of 50 µg Salmeterol MDPI (Salm50DPI) twice daily (BID) in the morning and in the evening, one capsule of matching placebo from grey HandiHaler® and one capsule of matching placebo from the blue HandiHaler® in the morning. Each dose of study medication had to be taken approximately at the same time, with 12 hours between the evening and morning dose. Each treatment period was 6 weeks on average with no wash-out between the treatment periods. | 0 | None | 4 | 137 | 14 | 137 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Mastoiditis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Meningitis pneumococcal | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Pneumococcal infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Colon cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Hepatic neoplasm malignant | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Prostate cancer | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 12.1 | View |
| Haemorrhagic anaemia | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 12.1 | View |
| Intracranial aneurysm | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Subarachnoid haemorrhage | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 12.1 | View |
| Cardiac failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| Congestive cardiomyopathy | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| Right ventricular failure | SYSTEMATIC_ASSESSMENT | Cardiac disorders | MedDRA 12.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Diarrhoea haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Diverticulum intestinal haemorrhagic | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Gastrointestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Intestinal haemorrhage | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | MedDRA 12.1 | View |
| Cholecystitis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
| Cholelithiasis | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 12.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 12.1 | View |
| Chronic obstructive pulmonary disease | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |
| Dyspnoea | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 12.1 | View |