Evidence map›Paper›PMID 29263536›Full record

ArticleIndian journal of dermatology

Cutaneous Adverse Drug Reactions in a Tertiary Care Teaching Hospital in India: An Intensive Monitoring Study.

Sejal Thakkar, Tejas K Patel, Roshni Vahora, Prakash Bhabhor, Raksha Patel

Open access · diamondAbstract read
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Article in Indian journal of dermatology. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
2.3field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 27 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 1 institution in 1 country.

Sejal ThakkarDepartment of Skin and VD, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
Tejas K PatelDepartment of Pharmacology, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
Roshni VahoraDepartment of Skin and VD, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
Prakash BhabhorDepartment of Pharmacology, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
Raksha PatelDepartment of Skin and VD, GMERS Medical College, Gotri, Vadodara, Gujarat, India.
Sir Sayajirao General Hospital Medical College · IN

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe epidemiological data based on intensive monitoring studies are limited for the cutaneous adverse drug reactions (CADRs) in terms of incidence. Most of earlier Indian studies focused only on types and causative drugs of CADRs.

aimThe aim of this study is to analyze the CADRs with reference to the incidence, its subgroup analysis, causative drugs, and other clinical characteristics in Indian population. METHODOLOGY: Intensive monitoring study was carried out over a period of 3 years in the dermatology outpatient and inpatient department. CADRs due to only systematically administered drugs were considered. The WHO definition for CADR, the WHO causality definitions, modified Schumock and Thornton's criteria for preventability, and International Conference on Harmonisation E2A guidelines for seriousness were considered. Incidence was expressed in percentage and its 95% confidence interval. The incidence was analyzed on basis of characteristics of study population and CADRs.

resultsA total of 171 CADRs were observed from 37,623 patients. The CADR incidence was 0.45% (95% CI: 0.39-0.53). The incidence did not significantly differ in different age groups and gender. Commonly observed CADRs were maculopapular rash (23.98%), urticaria (21.64%), and fixed drug eruptions (FDEs) (18.13%). Antimicrobials (35.18%) and nonsteroidal anti-inflammatory drugs (NSAIDs) were suspected in all common CADRs. Anti-infective and NSAIDs were most commonly suspected drugs in overall CADRs, maculopapular rash, urticaria, FDEs, and erythema multiforme. The exact nature of drugs remained inaccessible in one-fourth cases due to use of the over-the-counter self-medications. The incidence of preventable and serious and fatal CADRs was 0.08% (95% CI: 0.05-0.11), 0.04% (95% CI: 0.02-0.06), and 0.003% (95% CI: 0.000-0.001), respectively.

conclusionEthnic characteristics should be considered while interpreting incidence from the international studies. The demographic characteristics of study population do not affect the incidence of CADRs. Indian patients should be sensitized about hazards of self-medications.

Indexed as

Causative drugscutaneous adverse drug reactionsincidence

Identifiers

PMID29263536
PMCPMC5724310
OpenAlexW2768745964

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LicenceCC BY-NC-SA
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.