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 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
NCT ID:
NCT00340704
Description:
Subjects were titrated to their efficacious dose.Based on LPP results,subjects could remain on that dose if it was found to be efficacious or titrate up to their higher doses which might have provided some efficacy.Therefore some of the subjects were counted more than once for having reported adverse events with different doses of the study.
Frequency Threshold:
5
Time Frame:
From first drug administration until 28 days after last study drug administration, upto 80 days (Steady State - PK study), upto 450 days (Group D-Denovo) and upto 395 days (Group D-527.51 Rollover).
Study:
NCT00340704
Study Brief:
PK/PD, Long-term Safety and Efficacy of Tamsulosin Treatment in Children With Neurogenic Bladder
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Tamsulosin - Low Dose Level (Steady State - PK Study) | Subjects randomized to low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. | None | None | 0 | 10 | 5 | 10 | View |
| Tamsulosin - Medium Dose Level (Steady State - PK Study) | Subjects randomized to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. | None | None | 1 | 10 | 5 | 10 | View |
| Tamsulosin - High Dose Level (Steady State - PK Study) | Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd \& body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. | None | None | 0 | 10 | 3 | 10 | View |
| Tamsulosin - Low Dose Level (Group D-Denovo) | Subjects received low dose level (0.001 - 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1- 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. | None | None | 2 | 82 | 51 | 82 | View |
| Tamsulosin - Medium Dose Level (Group D-Denovo) | Subjects who were titrated to medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1-100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. | None | None | 3 | 61 | 25 | 61 | View |
| Tamsulosin - High Dose Level (Group D-Denovo) | Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd \& body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. | None | None | 4 | 41 | 33 | 41 | View |
| Tamsulosin - Low Dose Level (Group D-527.51 Rollover) | Subjects received low dose level (0.001-0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast. | None | None | 1 | 93 | 31 | 93 | View |
| Tamsulosin - Medium Dose Level (Group D-527.51 Rollover) | Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. | None | None | 1 | 41 | 10 | 41 | View |
| Tamsulosin - High Dose Level (Group D-527.51 Rollover) | Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast. | None | None | 1 | 29 | 9 | 29 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Peritoneal cyst | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 11.1 | View |
| Gastroenteritis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Hydrocephalus | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 11.1 | View |
| Tibial torsion | SYSTEMATIC_ASSESSMENT | Congenital, familial and genetic disorders | 11.1 | View |
| Cellulitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Dengue fever | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Pneumonia | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Ventriculoperitoneal shunt malfunction | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | 11.1 | View |
| Tethered cord syndrome | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 11.1 | View |
| Asthma | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 11.1 | View |
Other Events(If Any):
Other Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Abdominal pain | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 11.1 | View |
| Abdominal pain upper | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 11.1 | View |
| Diarrhoea | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 11.1 | View |
| Vomiting | SYSTEMATIC_ASSESSMENT | Gastrointestinal disorders | 11.1 | View |
| Catheter related complication | SYSTEMATIC_ASSESSMENT | General disorders | 11.1 | View |
| Mass | SYSTEMATIC_ASSESSMENT | General disorders | 11.1 | View |
| Pyrexia | SYSTEMATIC_ASSESSMENT | General disorders | 11.1 | View |
| Suprapubic pain | SYSTEMATIC_ASSESSMENT | General disorders | 11.1 | View |
| Cervicitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Influenza | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Nasopharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Pharyngitis | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Upper respiratory tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Urinary tract infection | SYSTEMATIC_ASSESSMENT | Infections and infestations | 11.1 | View |
| Body temperature increased | SYSTEMATIC_ASSESSMENT | Investigations | 11.1 | View |
| Dizziness | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 11.1 | View |
| Headache | SYSTEMATIC_ASSESSMENT | Nervous system disorders | 11.1 | View |
| Nervousness | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | 11.1 | View |
| Hydronephrosis | SYSTEMATIC_ASSESSMENT | Renal and urinary disorders | 11.1 | View |
| Cough | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 11.1 | View |
| Oropharyngeal pain | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 11.1 | View |
| Respiratory tract congestion | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | 11.1 | View |
| Rash | SYSTEMATIC_ASSESSMENT | Skin and subcutaneous tissue disorders | 11.1 | View |
| Orthostatic hypotension | SYSTEMATIC_ASSESSMENT | Vascular disorders | 11.1 | View |