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FDA required the sponsor to halt enrollment in the trial and transition participants to available therapies for the treatment of their disease. The trial was subsequently terminated once participants were transitioned.
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This is an extension of Protocol PRO 140_CD 01 to further evaluate the long-term suppression of HIV-1 replication following substitution of stable combination antiretroviral therapy with a PRO 140 (Monoclonal CCR5 antibody) monotherapy in adult subjects with HIV-1 infection
This study is a Phase 2b, multi-center, extension study designed to evaluate the long-term efficacy, safety, and tolerability of PRO 140 monotherapy for the maintenance of viral suppression in patients who were stable on combination antiretroviral therapy and completed 12 weeks of treatment under PRO 140_CD 01 Treatment Substitution Study without experiencing virologic failure.
Consenting patients will continue to receive PRO 140 monotherapy until investigational product (IP) receives marketing approval or investigational new drug (IND) is withdrawn by Sponsor. There is one week overlap of existing retroviral regimen and PRO 140 at the end of the treatment extension phase in subjects who do not experience virologic failure.
PRO 140 will be administered as a 350 mg subcutaneous injection weekly during treatment extension phase. Study participants will be monitored for viral rebound on a weekly basis following initiation of PRO 140 monotherapy and will re-initiate their previous antiretroviral regimen if plasma HIV-1 RNA levels rise above 400 copies/ml on two consecutive blood draws at least 3 days apart.
.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO 140 | Experimental | PRO 140 350mg weekly subcutaneous (SC) injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO 140 350mg weekly subcutaneous (SC) injection. | Drug | CCR5 Antagonist |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to Virologic Failure After Initiating PRO 140 Monotherapy | Virologic failure (VF) is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. The time to VF will be compared to a historical data (i.e., time to HIV-1 RNA viral load > 500 copies/mL of 29 days). The statistical comparison will be conducted using Wilcoxon rank sum test and the median time to Virologic Failure for this study will be compared to 30 days. | From treatment extension visit 1 (TE1) until virologic failure, assessed up to 125 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Virologic Failure After Initiating PRO 140 Monotherapy. | Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. | From treatment extension visit 1 (TE1) until virologic failure, assessed up to 125 weeks. |
| Mean Change in Viral Load (HIV-1 RNA Levels) |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants(Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions. | Tolerability of repeated subcutaneous administration of PRO 140 was planned to be assessed by the study participants using a Visual Analogue Scale, and by investigator-evaluation of injection site reactions. Injection site reaction assessment was not completed when subjects performed self-administration. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob Lalezari, MD | CytoDyn, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CD01-Extension Investigational Site | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35358290 | Derived | Chang XL, Reed JS, Webb GM, Wu HL, Le J, Bateman KB, Greene JM, Pessoa C, Waytashek C, Weber WC, Hwang J, Fischer M, Moats C, Shiel O, Bochart RM, Crank H, Siess D, Giobbi T, Torgerson J, Agnor R, Gao L, Dhody K, Lalezari JP, Bandar IS, Carnate AM, Pang AS, Corley MJ, Kelly S, Pourhassan N, Smedley J, Bimber BN, Hansen SG, Ndhlovu LC, Sacha JB. Suppression of human and simian immunodeficiency virus replication with the CCR5-specific antibody Leronlimab in two species. PLoS Pathog. 2022 Mar 31;18(3):e1010396. doi: 10.1371/journal.ppat.1010396. eCollection 2022 Mar. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO 140 | PRO 140 350mg weekly SC injection. PRO 140 350mg weekly SC injection.: C-C chemokine receptor type 5 (CCR5) Antagonist |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects with HIV-1 infection who did not experience virologic failure while in the treatment phase of the PRO 140_CD 01 study.
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO 140 | PRO 140 350mg weekly SQ (subcutaneous) injection. PRO 140 350mg weekly SQ injection.: CCR5 Antagonist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Time to Virologic Failure After Initiating PRO 140 Monotherapy | Virologic failure (VF) is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. The time to VF will be compared to a historical data (i.e., time to HIV-1 RNA viral load > 500 copies/mL of 29 days). The statistical comparison will be conducted using Wilcoxon rank sum test and the median time to Virologic Failure for this study will be compared to 30 days. | The efficacy population consists of all subjects who received at least one dose of leronlimab (PRO 140). | Posted | Mean | Standard Deviation | days | From treatment extension visit 1 (TE1) until virologic failure, assessed up to 125 weeks. |
|
Adverse events were reported from the time of the first treatment and continued up until the final study visit to evaluate safety of PRO140 (up to a maximum of 91 months).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRO 140 | PRO 140 350mg weekly SQ injection. PRO 140 350mg weekly SQ injection.: CCR5 Antagonist |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthma | Respiratory, thoracic and mediastinal disorders | MadDRA 25.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back Pain | Musculoskeletal and connective tissue disorders | MadDRA 25.1 | Systematic Assessment |
Certain lab data were not collected or were otherwise unavailable for analysis or reporting.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joseph Meidling | CytoDyn | (360) 980-8524 | jmeidling@cytodyn.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 2, 2021 | Mar 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 15, 2020 | Mar 11, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D000163 | Acquired Immunodeficiency Syndrome |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C420063 | leronlimab |
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Mean change from baseline of HIV-1 RNA levels was assessed for each week during the treatment phase up until week 58. Weighted mean change in viral load (HIV-1 RNA levels) were calculated from baseline to week 58. |
| From treatment extension visit TE2 (defined as baseline), until week 58 of extension treatment. |
| Mean Change in CD4 Cell Count | Mean change in CD4 cell count from baseline (TE2 visit) was assessed for each week during the treatment phase up until week 58. The average mean change was calculated from baseline to week 58. | From treatment extension visit TE2 (defined as baseline), until week 58 of extension treatment. |
| Change in Quality of Life Metrics (up to TE107) | A Quality of Life (QoL) assessment using ACTG SF-21 was planned to be performed at screening visit (SV1), once every four weeks from treatment visit 4 (TE4) through treatment visit 107 (TE107), and at end of treatment (EOT). The ACTG SF-21 has 8 QoL domains with a standard score ranging from 0 (worst) to 100 (best). | From TE4 (baseline) through every fourth weekly visits to treatment visit 107 (TE107) or EOT, up to 125 weeks. |
| From TE1 (first treatment administration) weekly until last treatment visit (up to 125 weeks) |
| Number of Participants With Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale | The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines:
| From the first treatment visit (TE1) until final study visit, up to a 125 weeks. |
| Number of Participants With at Least One Treatment-related Serious Adverse Event. | Treatment-related serious adverse events are defined as serious events with an onset on or after the first treatment. A serious adverse event is defined as any adverse event that:
| From the first treatment visit (TE1) until final study visit up to 125 weeks. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Time since HIV Diagnosis | Time in years since HIV original diagnosis taken at visit 1 | Mean | Full Range | years |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Proportion of Participants With Virologic Failure After Initiating PRO 140 Monotherapy. | Virologic failure is defined as two consecutive HIV-1 RNA levels of ≥ 400 copies/ml separated by at least 3 days. | The efficacy population consists of all subjects who received at least one dose of leronlimab (PRO 140). | Posted | Number | proportion of participants | From treatment extension visit 1 (TE1) until virologic failure, assessed up to 125 weeks. |
|
|
|
| Secondary | Mean Change in Viral Load (HIV-1 RNA Levels) | Mean change from baseline of HIV-1 RNA levels was assessed for each week during the treatment phase up until week 58. Weighted mean change in viral load (HIV-1 RNA levels) were calculated from baseline to week 58. | The efficacy population consists of all subjects who received at least one dose of leronlimab (PRO 140). Baseline was defined as TE2. Any subjects with an undefined change from baseline due to missing data were excluded. The following imputations were used in the statistical analysis: "<40" copies/mL as 40 "Target not detected" as 20. | Posted | Mean | Standard Deviation | copies/mL | From treatment extension visit TE2 (defined as baseline), until week 58 of extension treatment. |
|
|
|
| Secondary | Mean Change in CD4 Cell Count | Mean change in CD4 cell count from baseline (TE2 visit) was assessed for each week during the treatment phase up until week 58. The average mean change was calculated from baseline to week 58. | The efficacy population consists of all subjects who received at least one dose of leronlimab (PRO 140). Baseline was defined as TE2. Any subjects with an undefined change from baseline due to missing data were excluded. | Posted | Mean | Standard Deviation | cells/uL | From treatment extension visit TE2 (defined as baseline), until week 58 of extension treatment. |
|
|
|
| Secondary | Change in Quality of Life Metrics (up to TE107) | A Quality of Life (QoL) assessment using ACTG SF-21 was planned to be performed at screening visit (SV1), once every four weeks from treatment visit 4 (TE4) through treatment visit 107 (TE107), and at end of treatment (EOT). The ACTG SF-21 has 8 QoL domains with a standard score ranging from 0 (worst) to 100 (best). | No QoL data was collected at screening visit (SV1) for any of the participants. For 5 participants Quality-of-life (QoL) results were either not collected or they had undefined change from baseline due to missing data. | Posted | Mean | Standard Deviation | score | From TE4 (baseline) through every fourth weekly visits to treatment visit 107 (TE107) or EOT, up to 125 weeks. |
|
|
|
| Other Pre-specified | Tolerability of Repeated Subcutaneous Administration of PRO 140 as Assessed by Study Participants(Using Visual Analogue Scale) and by Investigator-evaluation of Injection Site Reactions. | Tolerability of repeated subcutaneous administration of PRO 140 was planned to be assessed by the study participants using a Visual Analogue Scale, and by investigator-evaluation of injection site reactions. Injection site reaction assessment was not completed when subjects performed self-administration. | Data on tolerability of repeated subcutaneous (SC) administration of PRO 140 was not collected. | Posted | From TE1 (first treatment administration) weekly until last treatment visit (up to 125 weeks) |
|
|
| Other Pre-specified | Number of Participants With Grade 3 or 4 Adverse Events as Defined by the DAIDS Adverse Event Scale | The Division of AIDS (DAIDS) grading table provides an adverse event severity grading scale ranging from grades 1 to 5 with descriptions for each adverse event based on the following general guidelines:
| All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population. | Posted | Count of Participants | Participants | From the first treatment visit (TE1) until final study visit, up to a 125 weeks. |
|
|
|
| Other Pre-specified | Number of Participants With at Least One Treatment-related Serious Adverse Event. | Treatment-related serious adverse events are defined as serious events with an onset on or after the first treatment. A serious adverse event is defined as any adverse event that:
| All patients who received at least one dose of PRO 140 (leronlimab) were included in the baseline analysis population. | Posted | Count of Participants | Participants | From the first treatment visit (TE1) until final study visit up to 125 weeks. |
|
|
|
| 0 |
| 20 |
| 4 |
| 20 |
| 15 |
| 20 |
| Intestinal Perforation | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Suicide Attempt | Psychiatric disorders | MadDRA 25.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MadDRA 25.1 | Systematic Assessment |
|
| Chest Pain | General disorders | MadDRA 25.1 | Systematic Assessment |
|
| Bile duct stone | Hepatobiliary disorders | MadDRA 25.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MadDRA 25.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | MadDRA 25.1 | Systematic Assessment |
|
| Colitis | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Epididymitis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Eye pain | Eye disorders | MadDRA 25.1 | Systematic Assessment |
|
| Fungal skin infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Influenza | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Meniscus injury | Injury, poisoning and procedural complications | MadDRA 25.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MadDRA 25.1 | Systematic Assessment |
|
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Abscess limb | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MadDRA 25.1 | Systematic Assessment |
|
| Burning sensation | Nervous system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Carpal tunnel syndrome | Nervous system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Cellulitis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Chills | General disorders | MadDRA 25.1 | Systematic Assessment |
|
| Chlamydial infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Craniocerebral injury | Injury, poisoning and procedural complications | MadDRA 25.1 | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | MadDRA 25.1 | Systematic Assessment |
|
| Depression | Psychiatric disorders | MadDRA 25.1 | Systematic Assessment |
|
| Dissociation | Psychiatric disorders | MadDRA 25.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Drug Abuse | Psychiatric disorders | MadDRA 25.1 | Systematic Assessment |
|
| Ear infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MadDRA 25.1 | Systematic Assessment |
|
| Eye infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MadDRA 25.1 | Systematic Assessment |
|
| Fatigue | General disorders | MadDRA 25.1 | Systematic Assessment |
|
| Folliculitis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Foot fracture | Injury, poisoning and procedural complications | MadDRA 25.1 | Systematic Assessment |
|
| Gastroenteritis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Gastrooeophageal reflux disease | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Giardiasis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Haematochezia | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Hernia | General disorders | MadDRA 25.1 | Systematic Assessment |
|
| Herpes simplex | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Hyperkeratosis | Skin and subcutaneous tissue disorders | MadDRA 25.1 | Systematic Assessment |
|
| Hypertension | Vascular disorders | MadDRA 25.1 | Systematic Assessment |
|
| Hyporeflexia | Nervous system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Hypotension | Vascular disorders | MadDRA 25.1 | Systematic Assessment |
|
| Hypothyroidism | Endocrine disorders | MadDRA 25.1 | Systematic Assessment |
|
| Injection site haemorrhage | General disorders | MadDRA 25.1 | Systematic Assessment |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MadDRA 25.1 | Systematic Assessment |
|
| Intraocular pressure increased | Investigations | MadDRA 25.1 | Systematic Assessment |
|
| Lower respiratory tract infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Lymphadenopathy | Blood and lymphatic system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Malaise | General disorders | MadDRA 25.1 | Systematic Assessment |
|
| Migrane | Nervous system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Muscle disorder | Musculoskeletal and connective tissue disorders | MadDRA 25.1 | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MadDRA 25.1 | Systematic Assessment |
|
| Nasal Congestion | Respiratory, thoracic and mediastinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MadDRA 25.1 | Systematic Assessment |
|
| Night sweats | Skin and subcutaneous tissue disorders | MadDRA 25.1 | Systematic Assessment |
|
| Onychomycosis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Oral Candidiasis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Pancreatitis | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Pharyngeal erythema | Respiratory, thoracic and mediastinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Pharyngitis streptococcal | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Postoperative wound infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Pustule | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MadDRA 25.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MadDRA 25.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Seasonal allergy | Immune system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Shigella infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Sinusitis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Substance abuse | Psychiatric disorders | MadDRA 25.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MadDRA 25.1 | Systematic Assessment |
|
| Swelling face | General disorders | MadDRA 25.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Syphillis | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MadDRA 25.1 | Systematic Assessment |
|
| Testicular swelling | Reproductive system and breast disorders | MadDRA 25.1 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Thrombotic thrombocytopenic purpura | Blood and lymphatic system disorders | MadDRA 25.1 | Systematic Assessment |
|
| Tonsillar hypertrophy | Respiratory, thoracic and mediastinal disorders | MadDRA 25.1 | Systematic Assessment |
|
| Tooth infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Vaccination site rash | General disorders | MadDRA 25.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MadDRA 25.1 | Systematic Assessment |
|
| Viral infection | Infections and infestations | MadDRA 25.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MadDRA 25.1 | Systematic Assessment |
|
Not provided
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| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012897 | Slow Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |