Trial Outcomes & Findings for Drug Use Investigation Of Effexor (SECONDARY DATA COLLECTION STUDY; SAFETY AND EFFICACY OF EFFEXOR.UNDER JAPANESE MEDICAL PRACTICE) (NCT NCT02958527)

Last Updated: 2023-05-22

Results Overview

An adverse drug reaction (ADR) was any untoward medical occurrence attributed to Effexor in a participant who received Effexor. A serious ADR was a ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to Effexor was assessed by the physician.

Recruitment status

COMPLETED

Target enrollment

1408 participants

Primary outcome timeframe

12 weeks from the start date (up until 52 weeks)

Results posted on

2023-05-22

Participant Flow

Participant milestones

Participant milestones
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Overall Study STARTED	1408
Overall Study COMPLETED	1396
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Overall Study Not collected CRFs	12

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) n=1334 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Age, Customized <15 years	1 Participants n=1334 Participants
Age, Customized ≥15 and <65 years	1144 Participants n=1334 Participants
Age, Customized ≥65 years	189 Participants n=1334 Participants
Sex: Female, Male Female	687 Participants n=1334 Participants
Sex: Female, Male Male	647 Participants n=1334 Participants

PRIMARY outcome

Timeframe: 12 weeks from the start date (up until 52 weeks)

Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received Effexor at least once.

Outcome measures

Outcome measures
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) n=1334 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 2 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 3 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 4 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 5 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 6 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 7 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Number of Participants With Adverse Drug Reactions ADR	312 Participants	—	—	—	—	—	—
Number of Participants With Adverse Drug Reactions Serious ADR	4 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks from the start date ( up until 52 weeks)

Population: The efficacy analysis set comprised of participants in the safety analysis set who had effectiveness evaluation (overall evaluation by the physician based upon change in clinical symptoms and laboratory findings) at least once. Of the participants included in the efficacy analysis set (n=1312), 1259 participants had available data at baseline.

HAM-D17 is a standardized, clinician-administered rating scale that assesses 17 items characteristically associated with depression (symptoms such as depressed mood, work and activities, sleep, suicide, psychomotor agitation/retardation, appetite, sexual interest, anxiety, and somatic symptoms). The items of the HAM-D17 are rated on a scale of 0 to 2 (8 items) or from 0 to 4 (9 items), and the total score ranges from 0 to 52, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.

Outcome measures

Outcome measures
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) n=1259 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 2 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 3 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 4 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 5 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 6 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 7 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points Week 4 (n=468)	-6.0 Unit on a scale Standard Deviation 6.6	—	—	—	—	—	—
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points Week 8 (n=290)	-9.1 Unit on a scale Standard Deviation 7.4	—	—	—	—	—	—
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points Week 12 (n=667)	-12.3 Unit on a scale Standard Deviation 7.6	—	—	—	—	—	—
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points Week 16 (n=233)	-11.2 Unit on a scale Standard Deviation 8.2	—	—	—	—	—	—
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points Week 24 (n=124)	-12.0 Unit on a scale Standard Deviation 8.1	—	—	—	—	—	—
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points Week 36 (n=116)	-12.2 Unit on a scale Standard Deviation 8.8	—	—	—	—	—	—
Change From Baseline in the 17-item Hamilton Rating Scale for Depression (HAM-D17) Total Scores at Pre-specified Evaluation Points Week 52 (n=527)	-15.2 Unit on a scale Standard Deviation 9.1	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks from the start date ( up until 52 weeks)

MADRS is a clinician-administered rating scale that assesses the overall severity of depressive symptoms. The MADRS had a 10-item checklist (apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thoughts, and suicidal thoughts). Items are scored from 0 to 6, and the total score ranges from 0 to 60, higher scores indicating more severity. Change from baseline: mean score at observation minus mean score at baseline. Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.

Outcome measures

Outcome measures
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) n=902 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 2 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 3 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 4 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 5 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 6 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 7 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points Week 4 (n=298)	-7.5 Unit on a scale Standard Deviation 9.0	—	—	—	—	—	—
Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points Week 8 (n=175)	-11.6 Unit on a scale Standard Deviation 10.7	—	—	—	—	—	—
Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points Week 12 (n=501)	-15.4 Unit on a scale Standard Deviation 9.6	—	—	—	—	—	—
Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points Week 16 (n=173)	-15.0 Unit on a scale Standard Deviation 11.0	—	—	—	—	—	—
Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points Week 24 (n=93)	-13.9 Unit on a scale Standard Deviation 10.0	—	—	—	—	—	—
Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points Week 36 (n=81)	-15.7 Unit on a scale Standard Deviation 10.6	—	—	—	—	—	—
Change From Baseline in the Montgomery - Asberg Depression Rating Scale (MADRS) Total Scores at Pre-specified Evaluation Points Week 52 (n=414)	-19.6 Unit on a scale Standard Deviation 10.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 weeks from the start date (up until 52 weeks)

CGI-S is a 7-point clinician-administered rating scale that assesses overall severity of the current illness state. The score ranges from 1 to 7, higher scores indicating more affected: "1: normal, not at all ill," "2: borderline mentally ill," "3: mildly ill," "4: moderately ill," "5: markedly ill," "6: severely ill," or "7: among the most extremely ill patients." Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.

Outcome measures

Outcome measures
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) n=1 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 2 n=7 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 3 n=182 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 4 n=590 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 5 n=285 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 6 n=104 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 7 n=4 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Clinical Global Impressions-Severity Week 12 1: Normal, not at all ill	0 Participants	2 Participants	19 Participants	56 Participants	9 Participants	7 Participants	1 Participants
Clinical Global Impressions-Severity Week 12 2: Borderline mentally ill	0 Participants	1 Participants	45 Participants	98 Participants	38 Participants	15 Participants	1 Participants
Clinical Global Impressions-Severity Week 12 3: Mildly ill	0 Participants	0 Participants	24 Participants	133 Participants	52 Participants	10 Participants	0 Participants
Clinical Global Impressions-Severity Week 12 4: Moderately ill	0 Participants	0 Participants	2 Participants	45 Participants	61 Participants	10 Participants	0 Participants
Clinical Global Impressions-Severity Week 12 5: Markedly ill	0 Participants	0 Participants	0 Participants	2 Participants	13 Participants	7 Participants	0 Participants
Clinical Global Impressions-Severity Week 12 6: Severely ill	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	5 Participants	0 Participants
Clinical Global Impressions-Severity Week 12 7: Among the most extremely ill patients	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Clinical Global Impressions-Severity Week 52 1: Normal, not at all ill	0 Participants	0 Participants	27 Participants	76 Participants	40 Participants	16 Participants	1 Participants
Clinical Global Impressions-Severity Week 52 2: Borderline mentally ill	0 Participants	2 Participants	33 Participants	92 Participants	47 Participants	14 Participants	0 Participants
Clinical Global Impressions-Severity Week 52 3: Mildly ill	0 Participants	0 Participants	15 Participants	69 Participants	39 Participants	7 Participants	0 Participants
Clinical Global Impressions-Severity Week 52 4: Moderately ill	0 Participants	0 Participants	0 Participants	21 Participants	14 Participants	2 Participants	0 Participants
Clinical Global Impressions-Severity Week 52 5: Markedly ill	0 Participants	0 Participants	0 Participants	2 Participants	5 Participants	1 Participants	0 Participants
Clinical Global Impressions-Severity Week 52 6: Severely ill	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants	0 Participants
Clinical Global Impressions-Severity Week 52 7: Among the most extremely ill patients	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 weeks from the start date (up until 52 weeks)

CGI-I is a 7-point clinician-administered rating scale that assesses overall improvement of the disease/condition. The score ranges from 1 to 7, higher scores indicating more affected: was assessed as "1: markedly improved," "2: moderately improved," "3: mildly improved," "4: no change," "5: slightly worsened," "6: worsened," or "7: severely worsened." Evaluation was performed at Week 4, 8, 12, 16, 24, 36, and 52.

Outcome measures

Outcome measures
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) n=664 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 2 n=533 Participants Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 3 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 4 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 5 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 6 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) Baseline 7 Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Changes in the Clinical Global Impressions-Improvement 1: Markedly improved	199 Participants	235 Participants	—	—	—	—	—
Changes in the Clinical Global Impressions-Improvement 2: Moderately improved	175 Participants	178 Participants	—	—	—	—	—
Changes in the Clinical Global Impressions-Improvement 3: Mildly improved	212 Participants	88 Participants	—	—	—	—	—
Changes in the Clinical Global Impressions-Improvement 4: No change	70 Participants	28 Participants	—	—	—	—	—
Changes in the Clinical Global Impressions-Improvement 5: Slightly worsened	5 Participants	3 Participants	—	—	—	—	—
Changes in the Clinical Global Impressions-Improvement 6: Worsened	3 Participants	1 Participants	—	—	—	—	—
Changes in the Clinical Global Impressions-Improvement 7: Severely worsened	0 Participants	0 Participants	—	—	—	—	—

Adverse Events

EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride)

Serious events: 20 serious events

Other events: 495 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) n=1334 participants at risk Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Gastrointestinal disorders Alcoholic pancreatitis	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Jaundice cholestatic	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Liver disorder	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Immune system disorders Anaphylactic shock	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Pneumonia	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Meniscus injury	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Injury, poisoning and procedural complications Subdural haematoma	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bile duct cancer	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gastric cancer	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemia	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Pregnancy, puerperium and perinatal conditions Abortion spontaneous	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Completed suicide	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Depression	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Depressive symptom	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Hypomania	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Mania	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Suicidal ideation	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Suicide attempt	0.07% 1/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Other adverse events

Other adverse events
Measure	EFFEXOR SR CAPSULES (Venlafaxine Hydrochloride) n=1334 participants at risk Participants who received Effexor as indicated in the approved local product document were observed for a period of 12 weeks from the start date (up until 52 weeks). The dosage can be adjusted as per physician's discretion.
Cardiac disorders Palpitations	0.97% 13/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Ear and labyrinth disorders Tinnitus	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Abdominal discomfort	0.37% 5/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Abdominal pain	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Abdominal pain upper	0.37% 5/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Constipation	2.7% 36/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Diarrhoea	0.75% 10/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Eructation	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Gastritis	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Gastrointestinal disorder	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Nausea	5.7% 76/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Gastrointestinal disorders Vomiting	0.52% 7/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Chest pain	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Feeling abnormal	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Malaise	1.9% 26/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Thirst	0.37% 5/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
General disorders Withdrawal syndrome	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Hepatic function abnormal	0.90% 12/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Hepatic steatosis	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Hepatobiliary disorders Liver disorder	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Gastroenteritis	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Infections and infestations Nasopharyngitis	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Blood pressure increased	0.45% 6/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Investigations Weight increased	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Decreased appetite	0.97% 13/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Dyslipidaemia	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hypercholesterolaemia	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hyperlipidaemia	0.30% 4/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Metabolism and nutrition disorders Hyperphagia	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Musculoskeletal and connective tissue disorders Neck pain	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Akathisia	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Dizziness	1.9% 25/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Dysgeusia	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Headache	1.7% 23/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Hypersomnia	0.37% 5/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Hypoaesthesia	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Migraine	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Somnolence	4.0% 53/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Nervous system disorders Tremor	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Pregnancy, puerperium and perinatal conditions Pregnancy	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Anger	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Anxiety	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Hallucination, auditory	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Hypomania	0.37% 5/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Initial insomnia	0.30% 4/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Insomnia	2.9% 39/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Intentional self-injury	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Irritability	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Libido decreased	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Mania	0.37% 5/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Middle insomnia	0.45% 6/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Sleep disorder	0.37% 5/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Psychiatric disorders Suicidal ideation	0.37% 5/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Dysuria	0.45% 6/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Pollakiuria	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Renal and urinary disorders Urinary incontinence	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Reproductive system and breast disorders Ejaculation disorder	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Eczema	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.52% 7/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Skin and subcutaneous tissue disorders Night sweats	0.22% 3/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Vascular disorders Hypertension	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.
Vascular disorders Orthostatic hypotension	0.15% 2/1334 • 12 weeks from the start date (up until 52 weeks) The frequency of adverse events. The same event may appear as both an adverse event and a serious adverse event. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both serious and non-serious events during the study.

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Publication restrictions are in place

Restriction type: OTHER